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The use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking. To evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM. This was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017. Participants were allocated to immediate IBBR with or without ADM. The primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire. From start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11). Immediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits. ClinicalTrials.gov Identifier: NCT02061527.

The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67–5·43, p<0·001), reoperation (3·38, 2·10–5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24–9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. Pink Ribbon, Nuts-Ohra, and LifeCell.

The field of regenerative medicine is increasingly in need of effective and biocompatible materials for tissue engineering. Human acellular dermal matrix (hADM)-derived collagen matrices stand out as a particularly promising candidate. Their ability to preserve structural integrity, coupled with exceptional biocompatibility, positions them as a viable choice for tissue replacement. However, their clinical application has been largely confined to serving as scaffolds. This study aims to expand the horizon of clinical uses for collagen sheets by exploring the diverse cutting-edge clinical demands. This review illustrates the clinical utilizations of collagen sheets beyond traditional roles, such as covering skin defects or acting solely as scaffolds. In particular, the potential of Epiflex®, a commercially available and immediately clinically usable allogeneic membrane, will be evaluated. Collagen sheets have demonstrated efficacy in bone reconstruction, where they can substitute the induced Masquelet membrane in a single-stage procedure, proving to be clinically effective and safe. The application of these membranes allow the reconstruction of substantial tissue defects, without requiring extensive plastic reconstructive surgery. Additionally, they are found to be apt for addressing osteochondritis dissecans lesions and for ligament reconstruction in the carpus. The compelling clinical examples showcased in this study affirm that the applications of human ADM extend significantly beyond its initial use for skin defect treatments. hADM has proven to be highly successful and well-tolerated in managing various etiologies of bone and soft tissue defects, enhancing patient care outcomes. In particular, the application from the shelf reduces the need for additional surgery or donor site defects.

Introduction Augmentation rhinoplasty is one of five aesthetic surgeries in the world. Expanded polytetrafluoroethylene (ePTFE) has been reported as a rational choice to augment the nasal dorsum and tip. However, its application for nasal tip augmentation has some debates. This study presented a technique using ePTFE grafts combined with human acellular dermis matrix (HADM) to reconstruct a deformed nose caused by previous rhinoplasties. Methods 50 female patients who came to the hospital from 08/2022 to 09/2022 for surgical revision of their nasal deformity. ePTFE was applied to reconstruct the nasal dorsum, tip, and columella strut. HADM grafts were utilized to reinforce the reconstructed framework. Patients were evaluated for at least 12 months for both aesthetic and functional results. Results Postoperatively, the nasal dorsal length increased from 38.9 ± 1.32 to 43.4 ± 1.22 mm; while, the projection of the nasal tip also raised from 19.8 ± 1.16 to 23.9 ± 1.05 mm. 38 patients (76%) reported that their breathing and smelling were improved compared to preoperatively. No cases had implant reactions, extrusion, or warping columella strut. Most of the patients (84%) were satisfied with the surgical outcomes. Three patients (6%) had redness at the nasal tip. The nasal tip of ten patients (20%) was hardened for 3 months postoperatively. There were 6% of patients who developed an infection and 2% of patients had asymmetric soft tissues of the tip 3 postoperative months. Conclusion This technique brought satisfactory aesthetic and functional results to patients, with no extrusion or rejection observed 12 months postoperatively. Infection was a prominent complication that should be considered and strictly monitored. Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Background Several studies have reported the use of acellular dermal matrix in breast reconstruction. However, the primary role of acellular dermal matrix in these studies was to support the implant; there are no reports on the use of acellular dermal matrix exclusively as volume replacement. Thus, we aimed to evaluate the safety and effectiveness of filling of the defect with acellular dermal matrix in oncoplastic breast-conserving surgery. Methods We prospectively recruited 120 adult breast cancer patients who were scheduled to undergo oncoplastic breast-conserving surgery with acellular dermal matrix filling from 2017 to 2018. Intraoperatively, diced human acellular dermal matrix measuring 3–5 mm was used on each side to fill in the excisional defect immediately. After 6 months, satisfaction of the patients and surgeons with overall and cosmetic outcomes was evaluated with a survey using a 10-point scale. Postoperative complications were assessed at 2 weeks and 6 months postoperatively. Results Of the 117 patients who were evaluated for their satisfaction, 94.0% were strongly satisfied with the cosmetic outcomes and 90.4% were strongly satisfied overall. Patient overall satisfaction scores were higher than surgeon satisfaction scores ( p < 0.001). Of the 117 patients who underwent evaluation of complications 6 months postoperatively, six (5.1%) had hematoma and seven (6.0%) had seroma. The overall reoperation rate due to complications was 8.5%. Only two patients needed acellular dermal matrix removal due to hematoma and inflammation. Conclusion Oncoplastic breast-conserving surgery with acellular dermal matrix filling of defects can be performed safely with high cosmetic satisfaction. Trial registration ICTRP, KCT0003886; retrospectively registered May 3, 2019, http://apps.who.int/trialsearch/Trial2.aspx?TrialID=KCT0003886

Objectives This study evaluated the influence of different rehydration media and time periods on biomechanical and structural properties of different acellular collagen matrices (ACMs). Materials and methods Specimens of three ACMs (mucoderm®, Mucograft®, Dynamatrix®) were rehydrated in saline solution (SS) or human blood for different time periods (5–60 min). ACMs under dry condition served as controls. Biomechanical properties of the ACMs after different rehydration periods were determined by means of tensile testing. ACMs’ properties were further characterized using Fourier-transform-infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC). Results At dry conditions, mucoderm® presented the highest tensile strength (TS) and Dynamatrix® showed the maximum elastic modulus (EM; p each ≤0.036). Rehydration in SS and blood resulted in significant TS changes of mucoderm® ( p each ≤0.05). Concering E M, mucograft® showed significantly decreased values after rehydration in SS compared to Dynamatrix® and mucoderm® after 10 min ( p each ≤0.024). mucoderm® hydrated for 5 min in blood displayed nearly double TS and a significantly increased E M after 60 min ( p  = 0.043) compared to rehydration in SS. TS and E M values of Dynamatrix® and Mucograft® were not altered following rehydration in blood versus SS ( p each ≥0.053). FTIR analysis confirmed the recovery of the graft protein backbone with increased rehydration in all samples. DSC measurements revealed that tissue hydration decreased thermal stability of the investigated ACMs. Conclusion Our findings demonstrated that the rehydration protocol affects the biomechanical properties of ACMs. Clinical relevance Clinicians should be aware of altered handling and mechanical properties of ACMs following different rehydration protocols.

PurposePorcine acellular dermal matrix (PADM) has been promoted as a suitable material for the reinforcement of the abdominal wall in Ventral Hernia Working Group (VHWG) Grade 3/4 wounds by Ventral Hernia Working Group et al. (Surgery 148(3):544–548). We describe our experience of, and assess the mechanisms for the failure of PADM (PermacolTM) in intestinal and abdominal wall reconstruction (AWR) for enterocutaneous fistulation (ECF).MethodsAll patients referred to our unit who had PADM used for AWR and ECF were studied from a prospectively maintained database. Follow-up data until 31/12/2018 were analysed. PADM was explanted at further surgery and examined histologically.Results13 patients, (median age-58.5 years) underwent AWR with PADM reinforcement. Twelve of these (92%) patients had developed abdominal wall defects (AWD) and ECF following complications of previous surgery. Six patients underwent fistula takedown and AWR with PADM, of which 5(83%) refistulated. Seven patients referred to us had already undergone similar procedures in their referring hospitals and had also refistulated. Median (range) time to fistulation after AWR with PADM was 17 (7–240) days. In all cases, PADM had been used to bridge the defect and placed in direct contact with bowel. At reconstructive surgery for refistulation, PADM was inseparable from multiple segments of small intestine, necessitating extensive bowel resection. Histological examination confirmed that the PADM almost completely integrated with the seromuscular layer of the small intestine.ConclusionPADM may become inseparable from serosa of the human small intestinal serosa when it is left in the abdomen during reconstructive surgery. This technique is associated with recurrent intestinal fistulation and intestinal failure and should be avoided if at all possible.

Human Acellular Dermal Matrices (HADM) are employed in various reconstructive surgery procedures as scaffolds for autologous tissue regeneration. The aim of this project was to develop a new type of HADM for clinical use, composed of glycerolized reticular dermis decellularized through incubation and tilting in Dulbecco's Modified Eagle's Medium (DMEM). This manufacturing method was compared with a decellularization procedure already described in the literature, based on the use of sodium hydroxide (NaOH), on samples from 28 donors. Cell viability was assessed using an MTT assay and microbiological monitoring was performed on all samples processed after each step. Two surgeons evaluated the biomechanical characteristics of grafts of increasing thickness. The effects of the different decellularization protocols were assessed by means of histological examination and immunohistochemistry, and residual DNA after decellularization was quantified using a real-time TaqMan MGB probe. Finally, we compared the results of DMEM based decellularization protocol on reticular dermis derived samples with the results of the same protocol applied on papillary dermis derived grafts. Our experimental results indicated that the use of glycerolized reticular dermis after 5 weeks of treatment with DMEM results in an HADM with good handling and biocompatibility properties.

Introduction Transplantation of a cell-seeded graft may improve wound healing after radiotherapy. However, the survival of the seeded cells depends on a rapid vascularization of the graft. Co-culturing of adult stem cells may be a promising strategy to accelerate the vessel formation inside the graft. Thus, we compared the in vivo angiogenic potency of mesenchymal stem cells (MSC) and endothelial progenitor cells (EPC) using dorsal skinfold chambers and intravital microscopy. Materials and methods Cells were isolated from rat bone marrow and adipose tissue and characterized by immunostaining and flow cytometry. Forty-eight rats received a dorsal skinfold chamber and were divided into 2 main groups, irradiated and non-irradiated. Each of these 2 groups were further subdivided into 4 groups: unseeded matrices, matrices + fibroblasts + pericytes, matrices + fibroblasts + pericytes + MSCs and matrices + fibroblasts + pericytes + EPCs. Vessel densities were quantified semi-automatically using FIJI. Results Fibroblasts + pericytes − seeded matrices showed a significantly higher vascular density in all groups with an exception of non-irradiated rats at day 12 compared to unseeded matrices. Co-seeding of MSCs increased vessel densities in both, irradiated and non-irradiated groups. Co-seeding with EPCs did not result in an increase of vascularization in none of the groups. Discussion We demonstrated that the pre-radiation treatment led to a significant decreased vascularization of the implanted grafts. The augmentation of the matrices with fibroblasts and pericytes in co-culture increased the vascularization compared to the non-seeded matrices. A further significant enhancement of vessel ingrowth into the matrices could be achieved by the co-seeding with MSCs in both, irradiated and non-irradiated groups.

Background The current literature is void of evidence-based guidelines regarding optimal choice of mesh. We aim to perform a comparative outcome analysis of synthetic mesh and acellular dermal matrix (ADM) in Ventral Hernia Working Grade (VHWG) grade II hernias with primary fascial closure. Methods A retrospective review of patients undergoing ventral hernia repair (VHR) by the senior author (S.J.K.) from 2007 to 2012 was performed. Patients undergoing VHR with primary fascial closure were risk stratified using the VHWG defined grading system. Results Seventy-two patients met the abovementioned inclusion criteria with 45 receiving synthetic mesh and 27 receiving ADM. The mean length of follow-up was 12.1 ± 9.1 months. Patients were, on average, 53.2 ± 11.6 years of age with a BMI of 33.9 ± 10.6 kg/m 2 . The overall incidence of surgical site occurrence (SSO) in the cohort was 41.7 % and the incidence of hernia recurrence was 5.6 %. 30-day mortality was 1.2 %. Bivariate analysis demonstrated that obesity ( P  = 0.038) and number of comorbidities ( P  = 0.043) were associated with SSO. Bivariate analysis demonstrated that prior failed hernia, use of ADM, and operative time were associated with higher rates of hernia recurrence; however, adjusted multivariate regression found only prior failed hernia (OR = 4.1, P  = 0.03) and biologic mesh (OR = 3.4, P  = 0.046) to be independently associated with recurrent hernia. Comparison of mesh types revealed few differences in preoperative or operative characteristics between synthetic mesh and acellular dermal matrices (ADM). The rate of hernia recurrence was significantly higher with ADM (14.8 % vs. 0.0 %, P  = 0.017). Patients receiving ADM repairs incurred significantly greater cost ($56,142.1 ± 54,775.5 vs. $30,599.8 ± 39,000.8, P  < 0.001). Conclusions These data suggest synthetic mesh is indicated in higher risk VHWG grade II repairs. In comparison to ADM, synthetic mesh was associated with significantly fewer hernia recurrences and lower cost utilization at 1-year. Level of Evidence Prognostic/risk category, level III